NCT06525935已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Once-Weekly CT-388 Administered for 48 Weeks to Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 469
- 试验地点
- 63
- 主要终点
- Percent Change in Body Weight from Baseline to Week 48
研究概览
简要总结
This is a multi-center, randomized, double-blind, placebo-controlled, parallel group dose-finding study to evaluate the efficacy and safety of enicepatide at low, middle, and high doses in participants with obesity or who are overweight with at least one weight-related comorbidity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 to 75 years of age
- •Body mass index (BMI) ≥30.0 kg/m2, OR BMI ≥27.0 and <30.0 kg/m2 and previously diagnosed with at least 1 of the following weight-related comorbidities, such as: prediabetes, hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease
- •At least one self-reported unsuccessful effort to lose body weight
排除标准
- •Prior history/diagnosis/lab evidence of any type of diabetes mellitus (e.g., Type 1, Type 2, gestational), or a history of ketoacidosis or hyperosmolar state
- •Self-reported body weight change of >5 kg within 3 months before randomization
- •Any unbalanced/extreme diets within 3 months of the screening visit, or plan to be on such diets during the study
- •Current or recent participation in an organized weight reduction program
- •Current or recent use of any treatment that promotes weight loss or glucose metabolism
- •Current or recent use of treatment that may cause weight gain
- •Prior or planned surgical treatment for obesity
- •Clinically significant or active gastric emptying abnormality, malabsorption, or chronic use of medications that directly affect GI motility
- •History of chronic pancreatitis or acute pancreatitis within 6 months before screening
- •Have obesity induced by other endocrinologic disorders (e.g., Cushing syndrome) or diagnosed monogenetic or syndromic forms of obesity
- •History of major depressive disorder within 2 years of screening, or any history/diagnosis of other severe psychiatric conditions (Note: Prospective participants with depression or anxiety whose disease state, in the opinion of the Investigator, is considered stable and expected to remain stable throughout the course of the study, may be considered for inclusion)
- •Family or personal history of medullary thyroid carcinoma
- •Serum calcitonin ≥ 20 ng/L
- •Women who are pregnant, breastfeeding, or intend to become pregnant, or are of childbearing potential and not using a highly effective contraceptive method
研究组 & 干预措施
Arm 1: Placebo
Placebo Comparator
Placebo administered subcutaneously (SC) once weekly.
干预措施: Placebo (Drug)
Arm 6: Enicepatide Dose Level 5 (High)
Experimental
Enicepatide Dose Level 5 administered SC once weekly.
干预措施: Enicepatide (Drug)
Arm 2: Enicepatide Dose Level 1 (Low)
Experimental
Enicepatide Dose Level 1 administered SC once weekly.
干预措施: Enicepatide (Drug)
Arm 3: Enicepatide Dose Level 2
Experimental
Enicepatide Dose Level 2 administered SC once weekly.
干预措施: Enicepatide (Drug)
Arm 4: Enicepatide Dose Level 3
Experimental
Enicepatide Dose Level 3 administered SC once weekly.
干预措施: Enicepatide (Drug)
Arm 5: Enicepatide Dose Level 4
Experimental
Enicepatide Dose Level 4 administered SC once weekly.
干预措施: Enicepatide (Drug)
结局指标
主要结局
Percent Change in Body Weight from Baseline to Week 48
时间窗: Baseline to Week 48
次要结局
- Percent Change in Body Weight from Baseline to Week 48 by Obesity Class(Baseline to Week 48)
- Change in Body Mass Index (BMI) from Baseline to Week 48(Baseline to Week 48)
- Change in Waist-to-Hip Ratio from Baseline to Week 48(Baseline to Week 48)
- Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 48(Baseline and Week 48)
- Absolute Change in Body Weight (kg) from Baseline to Week 48(Baseline to Week 48)
- Change in Waist-to-Height Ratio from Baseline to Week 48(Baseline to Week 48)
- Change in Waist Circumference from Baseline to Week 48(Baseline to Week 48)
- Change in Hip Circumference from Baseline to Week 48(Baseline to Week 48)
- Change in Glycated Hemoglobin (HbA1c) from Baseline to Week 48(Baseline to Week 48)
- Change in Fasting C-peptide from Baseline to Week 48(Baseline to Week 48)
- Change in Fasting Plasma Glucose from Baseline to Week 48(Baseline to Week 48)
- Change in Fasting Insulin from Baseline to Week 48(Baseline to Week 48)
- Percentage of Participants with Shift in Glycemic Status from Baseline to Week 48, Based on Fasting Plasma Glucose and HbA1c(Baseline and Week 48)
- Change in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) from Baseline to Week 48(Baseline to Week 48)
- Change in Quantitative Insulin Sensitivity Check Index (QUICKI) from Baseline to Week 48(Baseline to Week 48)
研究者
研究点 (63)
Loading locations...
相似试验
进行中（未招募）
2 期
A Study of Enicepatide (CT-388) in Participants Who Are Overweight or Obese With Type 2 Diabetes MellitusOverweight or ObeseType 2 Diabetes Mellitus (T2DM)NCT06628362Carmot Therapeutics, Inc.447
已完成
2 期
Study on OMT-28 in Maintenance of Sinus Rhythm in Patients With Persistent Atrial Fibrillation (AF)Atrial FibrillationNCT03906799Omeicos Therapeutics GmbH136
已完成
2 期
Dexpramipexole Dose-Ranging Biomarker Study in Subjects With Eosinophilic AsthmaEosinophilic AsthmaAsthmaNCT04046939Knopp Biosciences534
已完成
3 期
Efficacy and Safety of SST 0225, a Topical Ibuprofen Cream, in the Treatment of Pain Associated With Acute Ankle SprainAcute Ankle SprainNCT01874626Strategic Science & Technologies, LLC305
已完成
3 期
Lumateperone for the Prevention of Relapse in Patients With SchizophreniaSchizophreniaNCT04959032Intra-Cellular Therapies, Inc.228